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Partnering With Patients for Improving Medication Safety During Transitions of Care: Implications for Work System Design

2020年1月27日 更新者:Johns Hopkins University
This project is to develop, implement, pilot evaluate, and disseminate a medication safety program (HomeTeam) that consolidates strategies to help patients by partnering with patients and their informal caregivers during transitions from hospital to home. Care transitions, especially from hospital to home, are high-risk periods for medication errors, and are frequently associated with serious adverse drug events (ADEs) and preventable readmissions. Older adults with multi-morbid conditions who have complex medication regimes are especially prone to these risks. Patients and family caregivers may experience a dramatic transition in roles and responsibilities immediately after hospital discharge. Patients and family caregivers are relatively passive recipients in their care and medication management in the hospital, but when patients arrive at home, patients have the primary responsibility for their care and medication use (with professional care providers switching to a 'supporting' function). Although this significant transition in the nature and intensity of patient work needs to be managed actively, often patients and family members are not adequately engaged and prepared in the hospital, and not effectively supported for safe medication use after hospital discharge. More specifically, patients and family members may not understand essential steps in the management of their condition, and have difficulty contacting appropriate health care practitioners for guidance. Although most organizations deploy multiple layers of interventions for improving care transitions, reducing postdischarge adverse drug events (ADEs), 30-day readmissions and emergency department (ED) visits, their impact to date has been small, and there remains significant and urgent need to fundamentally redesign the hospital-to-home care transition process. Investigators believe that one practical and potentially effective way for this 'much-needed' redesign is through engaging and supporting patients and families in safe medication use. Investigators' proposed program 'HomeTeam' will contain evidence-based tools and methods for engaging patients and shifting culture towards a truly patient-centered care for medication safety.

調査の概要

状態

引きこもった

詳細な説明

The 'HomeTeam will be developed and evaluated by completing 3 specific aims:

Aim #1: Develop components of a multi-faceted program (HomeTeam) that consolidates evidence-based practices in patient and family activation and engagement related to medication safety, with the goal to adequately and reliably support transitions from the hospital to the patient home "work system" for medication management. Inpatient stays and the hospital discharge periods will be targeted as opportunities in activating, engaging, and enabling patients and family members to improve medication safety.

(1a) Identify evidence-based practices in patient and family activation and engagement related to medication safety during care transitions.

  1. b) Develop program components (e.g., action-oriented patient/ family education, improved medication reconciliation, patient-centered rounds, learning systems through systematic feedback from home care professionals)-including tools to assess, prioritize, streamline, and integrate existing practices- aimed at engaging patients and families and supporting medication use safety during care transitions from hospital to home with a participatory design (PD) approach.

    Aim #2: Refine and implement the HomeTeam program in two organizations (one academic, one community hospital), with a peer-to-peer assessment methodology to identify and refine patient and family engagement practices for transitional care medication safety.

  2. a) Refine HomeTeam program through participatory design approach and peer-to-peer assessment

(2b) Implement and pilot test HomeTeam in all participating sites

Aim #3: Evaluate the implementation process and the impact of the toolkit 'HomeTeam' on medication safety after hospital discharge. Investigators will use a pre-post design to evaluate the impact of the toolkit over a one year period, focusing on 65 years of age and older medicine patients. The primary outcome is preventable and ameliorable adverse drug events (ADEs) after discharge. Secondary outcomes include 30-day post-discharge readmissions and ED visits due to medication-related issues process improvement assessment, patient-reported outcomes, and toolkit adoption assessment (e.g., acceptability, feasibility). Qualitative methods (post-implementation interviews with clinicians and patient/ family members) will be used as part of the evaluation.

Hypothesis: Investigators hypothesize that the HomeTeam Medication Safety Program will reduce preventable and ameliorable post-discharge 30-day ADEs in the following subpopulations: older adults with at least 5 medications discharged from hospital to home on (H01) anticoagulants, (H0b) opioids, (H0c) diabetes agents.

The project will be conducted in two hospitals: Bayview Medical Center (academic) and Howard County Medical Center (community). Dissemination plans include national medication safety organizations (e.g., Institute for Safe Medication Practices), patient safety organizations (e.g., Batz Patient Safety Foundation), and professional societies (e.g., Society of Hospital Medicine). Different dissemination modalities are planned, including story-telling through social media and short videos targeted for patients and clinicians.

研究の種類

介入

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Maryland
      • Baltimore、Maryland、アメリカ、21202
        • Johns Hopkins Univ Armstrong Institute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 65 and older
  • medicine patients
  • hospitalized from home
  • English speaking
  • no cognitive problems/ can consent

Exclusion Criteria:

  • surgery patients

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Pre-intervention
Routine/ standard care and retrospective chart review for identifying preventable and ameliorable Adverse drug events as baseline
実験的:Post-intervention
Hometeam toolkit interventions (including improved discharge education, proactive medication safety assessment in daily rounds and handoffs, safety briefings) applied in all hospitalist services.

A multi-component intervention (8S's)

  1. Safety at home through partnership.
  2. Safety risk assessment at the admission
  3. Safety agenda setting for coordinating efforts among professionals to prepare patient/ family for self-management
  4. Safety tools. Cognitive tools to support patient/family after discharge
  5. Safety education. Enhanced Patient/ family medication safety education
  6. Safety briefings with patient/family A mechanism to proactively address common and patient/family specific risks.
  7. Safety through learning routines across the care continuum
  8. Safety assessment after discharge

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Preventable adverse drug events
時間枠:30 days after hospital discharge
Preventable ADEs are injuries that could have bee n avoided, that is, an injury judged to probably be the result of an error or a system design flaw.
30 days after hospital discharge
Ameliorable adverse drug events
時間枠:30 days after hospital discharge
Ameliorable ADEs are injuries whose severity could have been substantially reduced if different actions or procedures had been performed or followed.
30 days after hospital discharge

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Ayse Gurses、Johns Hopkins University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2019年12月1日

一次修了 (予想される)

2022年8月1日

研究の完了 (予想される)

2022年10月1日

試験登録日

最初に提出

2018年5月17日

QC基準を満たした最初の提出物

2018年5月21日

最初の投稿 (実際)

2018年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月29日

QC基準を満たした最後の更新が送信されました

2020年1月27日

最終確認日

2020年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IRB00175392

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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